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Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus

NCT03610178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2025-11-21

No results posted yet for this study

Summary

This is a randomized controlled trial of different glycemic targets during tratment of women with GDM with assessement of epygenetic aspects of their effects on the fetus and pregnancy outcomes. This study is interventional, randomised controlled trial, open-label.

Conditions

  • Gestational Diabetes Mellitus

Interventions

OTHER

Very tight glycemic targets, life-style modification, insulin therapy if needed

All patients are assigned to life-style modification (diet and physical exercise). If target glucose levels (\<5.1 mmol/L fasting and \<7.0 mmol/L postprandial) are not achieved insulin therapy is started

OTHER

Tight-moderate glycemic targets, life-style modification, insulin therapy if needed

All patients are assigned to life-style modification (diet and physical exercise). If target glucose levels (\<5.3 mmol/L fasting and \<7.8 mmol/L postprandial) are not achieved insulin therapy is started

Sponsors & Collaborators

  • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

    lead OTHER

Principal Investigators

  • Griniva Elena, MD, PhD · Almazov NMRC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2022-06-10
Completion
2024-12-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03610178 on ClinicalTrials.gov